The identification of genetic variation that influences or determines the
response to immunosuppressive therapeutics

The identification of SNPs, haplotypes, or microsatellite polymorphisms that correlate with and/or predict differences in transplant outcomes in individuals due to race, gender, or ethnicity.

Application of rigorous statistical tools are used to analyze multi-dimensional genomic data and clinical data and evaluate multi-genic and varied therapeutic effects resulting from the limited numbers and the heterogeneous character of patients and patient groups.

The Statistical and Clinical Coordinating Center (SACCC) at Rho serves as a resource to GTCRP investigators based on the individual consortium research needs. In particular, all sites participating in the GTCRP submit clinical and genomic data to a central web-based study database maintained by the SACCC. The SACCC provides statistical expertise, data management, data quality assurance, adverse event reporting, and clinical site monitoring, and works with National Institute of Allergy and Infectious Disease (NIAID) staff to ensure that studies are conducted in compliance with Good Clinical Practice (GCP) and the federal regulations governing human subject’s research.

David Iklé (Ph.D., Senior Statistical Scientist) is the Principal Investigator for this coordinating center.

Protocol

Title

GEN-01

Using the Transcriptome of 1 Year Protocol Biopsies to Predict Functional Decline in Kidney Transplant Patients